FDA Adverse Event
Malfunction
Summary report: N
ABBOTT LABS AIM PLUS
MDR report key: 228675
·
Received June 22, 1999
Report
- Report Number
- MW1016597
- Event Type
- Malfunction
- Date Received
- June 22, 1999
- Date of Event
- June 20, 1999
- Report Date
- June 21, 1999
- Manufacturer
- ABBOTT LABORATORIES, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT'S PARENT REPORTED THAT PUMP WOULD NOT GO THROUGH SELF-TEST. NO DOSES MISSED. PUMP EXCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT LABS AIM PLUS | AMBULATORY INFUSION PUMP | FRN | ABBOTT LABORATORIES, INC. | AIM PLUS | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Other |